510(k) Report

FDA applicant

Optics Laboratory, Inc.

El Monte, CA3 decisions2005–20160 recalls

FDA records 3 decisions for Optics Laboratory, Inc. (El Monte, CA) from 2005 to 2016: 3 510(k) clearances. All are in product code LPN (Accessories, Soft Lens Products). Its devices cite 4 predicates, 1 of them its own earlier devices. No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, ophthalmic panel, where it files most

How often FDA has decided Optics Laboratory, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2016

2011: 12016: 1
2007high 1 (2011) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Optics Laboratory, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Optics Laboratory, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • LPNAccessories, Soft Lens Products3decisions

Whose devices does it build on?

Its devices cite 4 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 3 times; 1 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K110221Eye-Cept Sterile Saline SolutionOptics Laboratory, Inc. · 20113cite it

What has FDA decided for it lately?

  • K161622LensGiene Sterile Saline SolutionOptics Laboratory, Inc. · 2016
  • K110221Eye-Cept Sterile Saline SolutionOptics Laboratory, Inc. · 2011
  • K041008Eye-Cept Rewetting DropsOptics Laboratory, Inc. · 2005

All 3 as Optics Laboratory, Inc. →